Acne
Conditions
Brief summary
The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.
Detailed description
Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.
Interventions
DRUGIDP-123 Lotion
Lotion
DRUGTazorac Cream
Cream
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream). * Verbal and written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit). * Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit. * Subjects with facial acne inflammatory lesion count no less than 20 but no more than 40. * Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100. Key
Exclusion criteria
* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. * Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema. * Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * Subjects with a facial beard or mustache that could interfere with the study assessments. * Subjects with more than 2 facial nodules.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. | 15 Days | Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe) |
Countries
United States
Outcome results
None listed